The American Society for Microbiology (ASM) discusses with the U.S. Congress issues related to the adequacy of federal law relating to dangerous biological agents. It is the largest single life science society in the world with a membership of 42,000, and represents a broad spectrum of sub-disciplines, including medical microbiology, applied and environmental microbiology, virology, immunology, and clinical and public health microbiology. The Society’s mission is to enhance microbiology worldwide to gain a better understanding of basic life processes and to promote the application of this knowledge for improved health, economic and environmental well being.
It has a long history of bringing scientific, educational and technical expertise to bear on the safe study, handling and exchange of pathogenic microorganisms. The exchange of scientific information, including microbial strains and cultures, among scientists is absolutely essential to progress in all areas of research in microbiology.
It understands the unique nature of microbiology laboratories, the need for safety precautions in research with infectious agents and the absolute necessity for maintaining the highest qualifications for trained laboratory personnel. It conducts education and training programs, as well as publication of material related to shipping and handling of human pathogens. Through its Public and Scientific Affairs Board, it provides advice to government agencies and to Congress concerning technical and policy issues arising from control of biological weapons. The Society’s Task Force on Biological Weapons Control assists the government on scientific issues related to the verification of the Biological Weapons Convention (BWC).
It is acutely aware of the threat posed by the possible misuse of microbial agents as weapons of terror. Concerns that bioterrorists will acquire and misuse microorganisms as weapons have resulted in stricter controls on the possession, transfer, and use of biological agents to restrict access to only legitimate and qualified institutions, laboratories, and scientists. Over the past ten years, the ASM has worked with the Department of Health and Human Services (DHHS), the Centers for Disease Control and Prevention (CDC), the Department of Agriculture (USDA), and Congress to develop and establish legislation and regulations that are based on the key principle of ensuring protection of public safety without encumbering legitimate scientific and medical research or clinical and diagnostic medicine for the diagnosis and treatment of infectious diseases. The ASM has been an advocate of placing responsibility for the safe transfer of select agents at the level of individual institutions supported by government oversight and monitoring to minimize risks without inhibiting scientific research.
It notes that national security efforts to control biological weapons require that the United States increase biodefense and public health capabilities at the same time that it tries to develop safeguards to prevent the misuse of biological agents to harm the public health. Limiting the threat of bioterrorism includes reducing access to biological agents that might be used as weapons; however, combating infectious diseases and increasing medical preparedness against bioterrorism necessitates increasing biodefense, biomedical, and other life sciences research, including work on the same “threat” agents that could be used as biological weapons. As safeguards are developed, we must ensure that biomedical research, public health, and clinical diagnostic activities are not inhibited or we risk jeopardizing the public’s health and welfare.
Congress already has established a legal and regulatory framework to prevent the illegitimate use of toxins and infectious agents, outlawing virtually every step that would be necessary for the production and use of biological weapons. In doing so it has balanced assuring the availability of materials to the scientific and medical community for legitimate research purposes with preventing access to these agents for bioterrorism. For instance, the 1989 Biological Weapons Act authorizes the government to apply for a warrant to seize any biological agent, toxin, or delivery system that has no apparent justification for peaceful purposes, but exempts agents used for prophylactic, protective, or other peaceful purposes. Prosecution under this statute requires the government to prove that an individual did not intend to use the biological agents or toxins in a peaceful manner. The law also enables federal officials to intervene rapidly in cases of suspected violations, thereby decreasing the likelihood of bioterrorism while protecting legitimate scientific endeavors, such as biomedical research and diagnosis of infectious diseases.
The Antiterrorism and Effective Death Penalty Act of 1996 (the Act) broadens penalties for development of biological weapons and illegitimate uses of microorganisms to spread disease. ASM testified before the 104th Congress with respect to the control of the transfer of select agents that “have the potential to pose a severe threat to public health and safety” and contributed to the passage of Section 511(d) of the Act. The Act was intended to protect dual public interests of safety and free and open scientific research through promulgation of rules that would implement a program of registration of institutions engaging in the transfer of select agents. The transport of clinical specimens for diagnostic and verification purposes are exempt, although isolates of agents from clinical specimens must be destroyed or sent to an approved repository after diagnostic procedures are completed. The CDC is responsible for controlling shipment of those pathogens and toxins that are determined to be most likely for potential misuse as biological weapons. The ASM believes the CDC regulatory controls provide a sound approach to safeguard select agents from inappropriate use and should serve as a worldwide model for regulating shipment of these agents.
In her April 22, 1998, testimony before the Senate Subcommittee on Technology, Terrorism and Government Information Committee on the Judiciary and Select Committee on Intelligence, Attorney General Janet Reno stated that “mere possession of a biological agent is not a crime under federal law unless there is proof of its intended use as a weapon, notwithstanding the existence of factors, such as lack of scientific training, felony record, or mental instability, which raise significant questions concerning the individual’s ultimate reason for possessing the agent.” She, like other law enforcement officials, are troubled by the fact that someone can possess a biological agent that could be used as a weapon and not be in violation of a law unless one can establish intent. It is our understanding that the Department of Justice and other federal agencies have reviewed federal criminal statutes that could be expanded to make possession of certain biological agents illegal.
The ASM agrees that enhancing security and safety is a critical necessity when bioterrorism poses a credible threat to society. However, proposals intended to promote safety should not pose a threat to biomedical or other life sciences research and clinical diagnostic activities that are essential for public health. Unintended consequences could stifle the free exchange of microbial cultures among members of the scientific community and could even drive some microbiologists away from important areas of research. Ironically, extreme control measures to prevent bioterrorism, instead of enhancing global security, could prove detrimental to that goal if scientists can no longer obtain authenticated cultures. A key point is that natural infectious diseases are a greater threat than bioterrorism. Infectious diseases remain the major cause of death in the world, responsible for seventeen million deaths each year. Microbiologists and other researchers depend upon obtaining authenticated reference cultures as they work to reduce the incidence of and deaths due to infectious diseases. Dealing with the threatened misuse of microorganisms, therefore, will require thoughtful consideration and careful balancing of three compelling public policy interests.
We must acknowledge the terrible reality of terrorism within the United States and abroad from both foreign and United States origins. We cannot discount the possibility that, as unfathomable as it may be to the civilized mind, terrorism may take the form of bioterrorism. Most certainly, therefore, the government and scientific communities are duty bound to take every reasonable precaution to minimize any risk of terrorist use of microorganisms. The ASM is taking a proactive role in this regard. Even as we strive to prevent bioterrorism, we must candidly recognize that no set of regulations can provide absolute assurance that no act of bioterrorism will ever occur. Therefore, as we strive to prevent such acts, we also have a duty to pursue research and public health improvements aimed at developing the most effective possible responses to acts of biological terror. Research and public health responses related to effectively combating an act of terror are a critical component of the public policy response to the threat that exists.
While the possibility of a future act of biological terrorism is a terrible threat with which we must and will deal, the scourge of infectious diseases is a terrible reality that daily takes the lives of thousands of Americans and tens of thousands around the world. Infectious diseases are now the third leading cause of death in the United States. Research on the prevention and treatment of such diseases is critical to the well being of our entire population. In responding to the threat of terror, therefore, we must minimize any adverse impact upon vital clinical and diagnostic research related to infectious diseases.
Congress and federal agencies have appreciated these competing considerations and have sought to minimize interference with research through such measures as recognizing appropriate exemptions in regulating the handling of pathogenic microorganisms. As we have stated, past legislation has recognized the need for balancing these concerns. We know that such balancing will continue, and the ASM is committed to providing all available assistance in achieving balanced and effective responses to the threat to the public welfare.
It supports making it more difficult for bioterrorists to acquire agents that could be used as biological weapons and to make it easier for law enforcement officials to apprehend and to prosecute those who would misuse microorganisms and the science of microbiology. Its code of conduct specifies that microorganisms and the science of microbiology should be used only for purposes that benefit humankind and bioterrorism certainly is inimical to the aims of it and its members. The ASM established its Task Force on Biological Weapons to assist the government and the scientific and biomedical communities in taking responsible actions that would lower the risks of biological warfare and bioterrorism.
It supports measures to prohibit possession of listed biological agents or listed toxins unless they are held for legitimate purposes and maintained under appropriate biosafety conditions. Accordingly, it supports extending the current regulations implemented by the CDC to oversee the shipment of listed agents to include possession of cultures of those agents.
Although the ASM will not offer specific proposals today, we do think it will be useful to outline certain basic principles that we believe should be considered. Governmental responsibility for establishing, implementing, and monitoring programs related to biosafety should remain with the DHHS and CDC for human health and the USDA for animal and plant health. The CDC possesses institutional knowledge and expertise related to issues of biosafety and the designation, transportation, storage, and use of select agents. The CDC is well qualified to balance the real need for biosafety regulation with the critical need for scientific research, especially clinical and diagnostic research for the prevention, treatment, and cure of infectious diseases.
The CDC’s responsibilities should include duties to continue to establish and periodically revise the list of select agents; and in accord with proper administrative procedures, promulgate any additional regulatory measures related to registration of facilities, establishment of biosafety requirements, institution of requirements for safe transportation, handling, storage, usage, and disposal of select agents, and the auditing, monitoring, and inspection of registered facilities. The CDC should notify the Department of Justice about any concerns that it may have about institutions that possess select agents. Congress and the Administration must recognize that any expansion of existing regulations will require additional financial and other resources by the CDC. Based on surveys that ASM has performed, it is estimated that approximately 300 institutions possess select agents. Approximately half of those institutions are currently registered with the CDC pursuant to existing law. Registration of an additional 150 institutions, therefore, would impose additional expense and resource burdens upon the CDC that should be recognized and funded to ensure the timely and complete fulfillment of the CDC’s critical mission.
Congress, the CDC, and any other relevant governmental agencies must maintain their focus on the legitimate, important, and fundamental issues related to biosafety. In this regard, biosafety initiatives should be directed toward, and focused on institutions that utilize select agents for scientific purposes, regardless whether such institutions are in the academic, commercial, or governmental sectors. As in other areas concerning biological, chemical, and radiological safety, the focus for ensuring safety should be on the institution. The institution rather than any individual scientist should be responsible for registering possession and maintaining the proper biosafety conditions for storage and usage of the agent.
In this context, ASM supports registration with the CDC of every institution that possesses and retains viable cultures (preserved and actively growing) of select agents along with the concomitant duty to follow all regulatory requirements related to such possession and usage. Institutions and individuals, thus, would be prohibited from possessing cultures of select agents unless the agents are maintained under appropriate biosafety conditions.
The DHHS/CDC, acting in cooperation with the scientific and biomedical communities and with public notice and input, should establish the rules and provide for governmental monitoring. However, the registered institution must be responsible for assuring compliance with mandatory procedures and for assuring fully appropriate biosafety mechanisms, including appointment of a responsible official to oversee institutional compliance with biosafety requirements.
These institutional responsibilities include assuring safety through proper procedures and equipment and through training of personnel. Thus, the institution would bear the responsibility for training employees regarding the biosafety requirements, including the absolute necessity for following those requirements, and such duties as reporting isolation of select agents or any breach in a biosafety protocol.
As institutions comply with appropriate safeguards, scientists may undertake their research with knowledge of clear procedures and with assurance that compliance with such procedures will fulfill all governmental requirements related to select agents. The institutions would be required to maintain records of authorized users and to ensure that they are properly trained as is currently the case for work with radioisotopes. Intentional removal of select agents from a registered facility would subject the individual to criminal sanctions.
Congress and the CDC must balance the public interests of minimizing the threat of bioterrorism and assuring vigorous scientific research, especially research relating to clinical and diagnostic methods and to protecting the nation’s food supply. We must recognize that we are dealing with naturally occurring organisms that cause natural diseases. The focus should be on cultures of biological agents and quantities of toxins on the CDC select agent list in order to address any problem arising from an individual who may unknowingly pick up a dead deer mouse with Hantavirus, a handful of soil with Bacillus anthracis, a jar of honey with Clostridium botulinum, or contract an infectious disease with one of the select agents, and who could be in technical violation of a law prohibiting possession. Because microorganisms, including listed agents, are invisible and widely distributed, there is no way of knowing what you might possess unless you culture the organisms or use sophisticated molecular diagnostic procedures.
The CDC, working with the scientific community, should develop a comprehensive definition of a culture of a biological agent that would include microorganisms growing in artificial media, animal cells, and preserved viable materials from such cultures, which are the materials of concern.
Congress should recognize that the need to deal with the threat of biological terrorism will be an ongoing duty for the indefinite future and will continually require balancing competing considerations as discussed in our earlier testimony. Therefore, Congress, acting through the DHHS and CDC, should provide for continuing consultation with the scientific and biomedical communities regarding the substance and procedures of regulations governing select agents. The CDC should be empowered to act swiftly to adjust definitions, substantive duties, and procedural requirements to the inevitable changes resulting from scientific research. ASM is committed to working with Congress and the DHHS and CDC to protect against threats of terrorism while engaging in vigorous research for the betterment of humankind.